CitraNatal Medley

Storage

Storage: Store at 20(0)C to 25(0)C (68(0)F to 77(0)F), excursions permitted between 15(0)C and 30(0)C (between 59(0)F and 86(0)F). Brief exposure to temperatures up to 40(0)C (104(0)F) may be tolerated provided the mean kinetic temperature does not exceed 25(0)C (77(0)F); however, such exposure should be minimized.

General Statements: All Other Content

Notice: Contact with moisture can discolor or erode the soft gel.

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How Supplied: Bottles of 30 soft gels each – NDC 00178-0896-30.

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To report a serious adverse event or obtain product information, call (800) 298-1087.

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Please consult your health care provider with any dietary concerns.

Brand IP Statement(s) re: (c), (TM), (SM)

Ferr-Ease dual-Iron delivery Trademark of Mission Pharmacal Company U.S. Patent No. 6,521,247 life'sDHA CitraNatal Medley contains life'sDHA, a trademark of DSM. Copyright 2017 Mission Pharmacal Company. All rights reserved.

General: Product/Version Code

L089630R1017

General Statements: All Other Content

NDC 00178-0896-30

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Rx Only

Formula re: Type

Rx prenatal soft gel

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N

Precautions re: Children

Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

Precautions re: Pregnant or Nursing or Prescription Medications

Warning: Ingestion of more than 3 grams of omega-3 fatty acids per day has been shown to have potential antithrombotic effects, including an increased bleeding time and INR. Administration of omega-3 fatty acids should be avoided in patients on anticoagulants and in those known to have an inherited or acquired bleeding diathesis.

Precautions re: All Other

Warning: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

Formula re: Contains

Description: CitraNatal Medley is a prescription prenatal/postnatal multi-vitamin/mineral soft gel with Ferr-Ease, a patented dual-iron delivery comprising both a quick release and slow release iron, and DHA, an essential fatty acid.

General Statements: All Other Content

The prenatal vitamin is an oval, purple, opaque soft gel containing a greenish-grey liquid to semi-solid fill. The prenatal soft gel is printed “896” in white ink.

Formula re: Type

Indications: CitraNatal Medley is a multi-vitamin/mineral prescription drug indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the postnatal period for both lactating and nonlactating mothers.

Precautions re: All Other

Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Precautions re: All Other

Precautions: Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Precautions re: Allergies

Adverse Reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Precautions re: All Other

Caution: Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

Suggested/Recommended/Usage/Directions

Dosage And Administration: One prenatal soft gel daily or as directed by a physician.